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Central Vein Sign in Multiple Sclerosis Extension Study

RECRUITINGN/ASponsored by The Cleveland Clinic
Actively Recruiting
PhaseN/A
SponsorThe Cleveland Clinic
Started2025-10-07
Est. completion2026-12-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations3 sites

Summary

Multiple sclerosis (MS) is a common disease of the central nervous system that affects almost 1 million people in the United States. However, diagnosing MS can be difficult and often leads to misdiagnosis. More sensitive and specific biomarkers are needed to help with the diagnosis, prognosis, and evaluation of treatment response for MS. The central vein sign (CVS) and the paramagnetic rim lesion (PRL) are two biomarkers that have shown promise in improving diagnostic accuracy for MS. The goal of this study is to provide pilot information on the long-term performance of the CVS and PRL to help diagnose and follow people with MS. The study will follow 40 participants over 48 months to determine if the CVS and PRL help make a diagnosis of MS and how they can be used to follow people with MS. The study will also examine how PRL and CVS change over 48 months. The results of this pilot study will inform the development of a grant application to extend 5-year follow-up for all 420 participants of the CAVS-MS study. The study will use high-resolution T2\*-weighted MRI to detect the CVS and PRLs. An MRI of the brain with contrast will be used to examine CVS, PRL and longitudinal analysis of lesions that slowly grow over time (slowly expanding lesions \[SELs\]). The results of this study have the potential to improve the accuracy of diagnosing and treating MS.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

* Participants must be enrolled in and meet all inclusion criteria of the CAVS-MS study.
* Must have participated in the CAVS-MS study and have completed month 24 visits.
* Able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Contraindication to MRI studies; metal or metal implants incompatible with MRI
* Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g. tremor).

Conditions1

Multiple Sclerosis

Locations3 sites

California

1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048

Ohio

1 site
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Dawn Maniawski216 636-9196MANIAWD@ccf.org

Pennsylvania

1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Russell Shinohara

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